Alzheimer's Disease MedDRA version: 14.1 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc, 500 Arcola Road, Collegeville, PA 19426 USA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent in accordance with local regulations. The subject’s caregiver must also consent to participate in the study. 2. Diagnosis of probable Alzheimer’s disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer’s disease and Related Disorders (NINCDS-ADRDA) criteria. 3. Age 50 to 85 years at enrollment. 4. Mini-Mental Status Examination (MMSE) score of 21-26 in Germany only. 5. Rosen Modified Hachinski Ischemic score =65 years) yes F.1.3.1 Number of subjects for this age range 52
Exclusion criteria
Exclusion criteria: 1. Significant neurological disease, other than AD, that may affect cognition. 2. Screening visit brain MRI scan indicative of any other significant abnormality including but not limited to multiple microhemorrhages (2 or more) or evidence of a single prior hemorrhage > 1 cm3, multiple lacunar infarcts (2 or more) or evidence of a single prior infarct > 1 cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space-occupying lesions (eg, arachnoid cysts or brain tumors, such as meningioma). 3. Current presence of a clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR), or symptom (e.g., hallucinations), that could affect the subject’s ability to complete the study. 4. Current clinically significant systemic illness that is likely to result in deterioration of the subject’s condition or affect the subject’s safety during the study. 5. History of encephalitis. 6. History of clinically evident stroke or history of clinically significant carotid or vertebrobasilar stenosis or plaque. 7. History of seizures, excluding febrile seizures in childhood. 8. History or evidence of any clinically significant autoimmune disease or disorder of the immune system. 9. History or evidence of clinically significant renal disorder. 10. Clinically significant infection within the last 30 days (e.g., chronic persistent or acute infection eg. bronchitis). 11. Treatment with immunosuppressive medications (e.g., systemic corticosteroids) within the last 90 days (topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted) or chemotherapeutic agents for malignancy within the last 3 years. 12. Myocardial infarction within the last 2 years. 13. History of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma and squamous cell carcinoma of the skin. 14. Evidence of clinically significant uncontrolled hypertension. 15. Other clinically significant abnormality on physical, neurological, laboratory, or ECG examination (e.g., atrial fibrillation) that could compromise the study or be detrimental to the subject. 16. Hemoglobin less than 11g/dL. 17. Excessive smoking defined as > 20 cigarettes a day. 18. Multiple drug allergies. 19. History of alcohol or drug dependence or abuse within the last 2 years. 20. Hamilton Psychiatric Rating Scale for Depression (HAM-D17) (17 item) score >12. 21. Current use of anticonvulsants for seizure, anti-Parkinson’s, anticoagulant (except the use of aspirin 325 mg/day or less), clopidogrel [Plavix], CNS stimulants (e.g., methylphenidate [Ritalin]), or narcotic medications. 22. Current use of prescription or nonprescription (eg, Gnikgo Bioloba, huperzine) medication for cognitive enhancement other than cholinesterase inhibitors and memantine as previously described. 23. Subjects who have discontinued cholinesterase inhibitors, memantine, cognitive enhancing agents, or drugs that potentially affect cognition in the 60 days prior to baseline. 24. Unless maintained on a stable dose regimen for at least 30 days prior to baseline, any other medications with the potential to affect cognition other than cholinesterase inhibitors or memantine (including, but not limited to, anxiolytics, sedatives, hypnotics, antipsychotics, herbal, antidepressants, over-the-cou
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of multiple doses of ACC 001 in subjects with mild to moderate AD.;Secondary Objective: To assess the immunogenicity of each dose level of ACC 001 with or without QS-21 in subjects with mild to moderate AD. Exploratory objectives: To evaluate the efficacy of ACC 001 in subjects with mild to moderate AD.;Primary end point(s): The incidence and severity of treatment-emergent adverse events (TEAEs); Clinically important changes in safety assessment results (including AEs , vital signs, weight, clinical laboratory tests, electrocardiograms [ECGs], magnetic resonance imaging [MRI] scans, and physical and neurological exams).;Timepoint(s) of evaluation of this end point: At screening, Day 1 and each study visit thereafter | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints: - Change from baseline levels of anti-A-beta IgG total at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104; - Change from baseline levels of anti-A-beta IgM at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104; - If applicable, change from baseline levels of IgG subtypes at visits where an IgGtotal response is measurable. Exploratory End points: - change from baseline scores for the Neuropsychological Test Battery (NTB), the Alzheimer’s Disease Assessment Scale - Cognitive subscale (ADAS COG), Disability Assessment Scale for Dementia (DAD), Clinical Dementia Rating Sum of Boxes (CDR-SOB), Neuropsychiatric Inventory (NPI), and Mini-Mental State Exam (MMSE) at months 3, 6, 12, 18, and 24; - Change from baseline volumes for whole brain volume, brain boundary shift integral (BBSI), ventricular volume, hippocampal boundary shift integral (HBSI) and ventricular boundary shift integral (VBSI), at month 18 (Week 78). - To evaluate the change from baseline in cerebrospinal fluid (CSF) of A beta, anti-A-beta, tau and p-tau at week 50 and 78;Timepoint(s) of evaluation of this end point: At screening, and at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, 104. | — |
Countries
France, Germany, Spain
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc
Outcome results
None listed